TERUMO CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (10)

Premarket Exempt

No Yes

Clear

HEARTRAIL - 04987350423870 Catalog Number : GC-U6TG400N

Device Description : HEARTRAIL III Guiding Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700025 Catalog Number : RH*5TIG110A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700049 Catalog Number : RH*5TIG210A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700063 Catalog Number : RH*5BL3520A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700087 Catalog Number : RH*5BL4020A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class :

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700100 Catalog Number : RH*5SP0061A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700124 Catalog Number : RH*5AP5561A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class :

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700148 Catalog Number : RH*5SL3500A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class :

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700162 Catalog Number : RH*5SL4000A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700186 Catalog Number : RH*5SL5000A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

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